Oct 1
Visual rhetoric and emotional interaction in Medical DevicesFrequently in the medical device industry, the tangible importance of the aesthetic design of an object can be downplayed. It can be considered dressing or fluff and not important in the development of the device. However, aesthetic personality, visual rhetoric or emotional interaction with a medical device influence the experience that an operator and a patient have with the device.
Sep 8
Creating a Custom-Built Reflow Oven
A fun side-project that I worked on during my co-op term here at StarFish Medical was a custom-built reflow oven to solder surface mount components onto printed circuit boards. Continue reading »
Sep 5
Variations Between FDA and EU MDR Requirements for Clinical Investigations
Clinical investigations are defined within both FDA and EU MDR as the systematic investigation involving one or more human subjects, undertaken to collect data and assess the safety or performance of a device. Using the clinical data to demonstrate that the device meets the safety and effectiveness considerations is an important step in the device lifecycle.
Here, we will look at some of the differences between FDA and EU MDR process and requirements for clinical investigations. Continue reading »
Sep 1
Qualifying Medical Device Development Tools (MDDT)
The US Food and Drug Administration (FDA)’s voluntary Qualification of Medical Device Development Tools (fda.gov) is intended to encourage use of innovative technologies and novel approaches to medical device development and create a favourable regulatory framework to expand the availability of entirely new medical devices to patients.
This blog includes an overview of MDDT program, its categories, history, benefits, Centre for Devices and Radiological Health (CDRH) Qualification Process and Decision Framework.
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Sep 1
5 Tips on Preparing for a Successful FDA Inspection
As you gear up to face your impending FDA inspection, we’re here to lend a helping hand with five crucial tips for a smooth and successful FDA inspection.
Navigating the intricacies of regulatory compliance can be daunting, but fear not! Our expert advice will guide you through this difficult process, so your organization is well prepared to meet the FDA’s requirements.
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Sep 1
Optimizing QA/RA Value in Medical Device Development
When thinking about the roles of Quality Assurance (QA) and Regulatory Affairs (RA), I like to use the metaphor of the trail blazer and the guide, RA is there to blaze the trail and find the path, QA is there to keep the team on that path and away from pitfalls and hazards.
RA does this by monitoring and reviewing the regulatory landscape, understanding the applicable laws and regulations, but also knowing about recent decisions by regulatory bodies and how interpretations of these directives and guidances can vary. QA keeps projects on track by being fully engaged in the Quality Management System (QMS) and knowing what needs to be done to ensure that the project is successful as well as compliant.
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Aug 18
Medical Device Phase One Product Development Pro Tips
Our employee experts share their best tips and examples for each phase of the commercialization process in a four-part series on Medical Device Commercialization. This blog covers Medical Device Phase One Product Development engineering, design and development. For Phase Zero tips, check out our blog on Product Definition.
Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing.
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Aug 9
Look Before you Lead: Planning for Summative / Human Factors Validation Testing
Human factors validation testing is the final usability testing to be completed prior to regulatory submission. A mistake or an omission may result in follow-up testing being required if you uncover unanticipated use errors during testing. Careful planning is highly recommended.
The following aspects should be considered for human factors validation planning. Each topic could be a chapter unto itself but for now we will keep it succinct.
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Aug 4
Patient-Centered Design
Patient-centered design is designing healthcare with the patient in mind, a methodology that prioritizes the patient’s desires and requirements. This encompasses constructing medical facilities, procedures, and systems to enhance patient care. The concept of patient-centered has gained considerable traction in recent years as healthcare organizations worldwide strive to improve their quality of care.
In this blog post, I will delve into the principles of patient-centered design advantages for patients and healthcare providers. Continue reading »
Aug 4
What is Pantone and how can I use it in Medical Device Development?
Color plays an important role in a product. It can define a brand identity and help usability of a product. When it comes to medical devices, the role of color becomes even more critical, guided by safety standards and regulatory requirements.
When we are describing color, we merely state them as “white”, “red”, “gray”, etc. However, when it comes to defining color of a product, it needs more accuracy since these words cover a wide range of shades with varying levels of brightness (saturation) and color quality (hue).
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Aug 4
5 Reasons Human Factors remain important in MedTech despite Artificial Intelligence
Medical devices play a vital role in modern healthcare, aiding in the diagnosis, treatment, and management of various medical conditions. However, the effectiveness and safety of these devices rely not only on technological advancements but also on their usability and compatibility with human factors. Continue reading »
Jul 1
How to Leverage PCB Mounted Microfluidic Cartridge Components
Microfluidic point-of-care assays are a hot topic nowadays and there’s lots of buzz surrounding how to make inexpensive, quick and reliable cartridges.
One area that gets less focus is how to design the actuation and quantification mechanisms within the instrument or reader.
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